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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K002616
Device Name ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
Applicant
Electric Mobility Corp.
1 Mobility Plaza
Sewell,  NJ  08080
Applicant Contact WALTER F ZARZYOKI
Correspondent
Electric Mobility Corp.
1 Mobility Plaza
Sewell,  NJ  08080
Correspondent Contact WALTER F ZARZYOKI
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/22/2000
Decision Date 12/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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